CA2560613C - Compositions pharmaceutiques par voie orale a base de lipases, en particulier de pancreatine, contenant des tensioacitfs - Google Patents

Compositions pharmaceutiques par voie orale a base de lipases, en particulier de pancreatine, contenant des tensioacitfs Download PDF

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Publication number
CA2560613C
CA2560613C CA2560613A CA2560613A CA2560613C CA 2560613 C CA2560613 C CA 2560613C CA 2560613 A CA2560613 A CA 2560613A CA 2560613 A CA2560613 A CA 2560613A CA 2560613 C CA2560613 C CA 2560613C
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Canada
Prior art keywords
mixture
surfactant
pharmaceutical composition
aliphatic
enzyme
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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CA2560613A
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English (en)
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CA2560613A1 (fr
Inventor
George Shlieout
Bernd Boedecker
Siegfried Schaefer
Bernd Thumbeck
Peter-Colin Gregory
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Abbott Laboratories GmbH
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Abbott Laboratories GmbH
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Priority claimed from EP04101164.4A external-priority patent/EP1579869A1/fr
Application filed by Abbott Laboratories GmbH filed Critical Abbott Laboratories GmbH
Publication of CA2560613A1 publication Critical patent/CA2560613A1/fr
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Publication of CA2560613C publication Critical patent/CA2560613C/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/54—Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/745—Polymers of hydrocarbons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/465—Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne des compositions pharmaceutiques à administration per os, faites de produits contenant des lipases, en particulier de la pancréatine ou des produits pancréatiniques, ou bien des produits enzymatiques contenant au moins une lipase d'origine non animale, en particulier microbienne. Ces compositions pharmaceutiques améliorent l'activité lipolytique et apportent en particulier une stabilisation de la lipase dans la plage de pH acide. Ces nouvelles compositions pharmaceutiques à administration per os se caractérisent en ce qu'elles contiennent un système comprenant au moins un tensioactif et au moins un co-tensioactif et éventuellement une phase lipophile, et qu'elles sont auto-émulsifiables au contact d'une phase hydrophile et lipophile. Ces nouvelles compositions conviennent bien pour le traitement et/ou la prophylaxie des troubles digestifs chez les mammifères et les humains, en particulier lorsqu'ils sont dus à une insuffisante pancréatique exocrine chronique.
CA2560613A 2004-03-22 2005-03-21 Compositions pharmaceutiques par voie orale a base de lipases, en particulier de pancreatine, contenant des tensioacitfs Expired - Lifetime CA2560613C (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US55499304P 2004-03-22 2004-03-22
US60/554,993 2004-03-22
EP04101164.4 2004-03-22
EP04101164.4A EP1579869A1 (fr) 2004-03-22 Composition pharmaceutique contenant une lipase, particulièrement la pancréatine, et des agents tensioactifs
PCT/EP2005/051295 WO2005092370A1 (fr) 2004-03-22 2005-03-21 Compositions pharmaceutiques par voie orale a base de lipases, en particulier de pancreatine, contenant des tensioacitfs

Publications (2)

Publication Number Publication Date
CA2560613A1 CA2560613A1 (fr) 2005-10-06
CA2560613C true CA2560613C (fr) 2015-11-24

Family

ID=34964300

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2560613A Expired - Lifetime CA2560613C (fr) 2004-03-22 2005-03-21 Compositions pharmaceutiques par voie orale a base de lipases, en particulier de pancreatine, contenant des tensioacitfs

Country Status (14)

Country Link
US (3) US8802087B2 (fr)
EP (1) EP1729797B1 (fr)
JP (1) JP5032300B2 (fr)
CN (1) CN1933850B (fr)
AT (1) ATE407693T1 (fr)
AU (1) AU2005227090B2 (fr)
BR (1) BRPI0509148B8 (fr)
CA (1) CA2560613C (fr)
DE (1) DE602005009677D1 (fr)
ES (1) ES2314646T3 (fr)
PL (1) PL1729797T3 (fr)
PT (1) PT1729797E (fr)
RU (1) RU2381813C2 (fr)
WO (1) WO2005092370A1 (fr)

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RU2381813C2 (ru) 2010-02-20
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BRPI0509148A (pt) 2007-09-11
HK1101342A1 (en) 2007-10-18
WO2005092370A1 (fr) 2005-10-06
ES2314646T3 (es) 2009-03-16
AU2005227090A1 (en) 2005-10-06
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BRPI0509148B1 (pt) 2016-07-12
EP1729797A1 (fr) 2006-12-13
CA2560613A1 (fr) 2005-10-06
DE602005009677D1 (de) 2008-10-23
RU2006137325A (ru) 2008-04-27
JP5032300B2 (ja) 2012-09-26
PL1729797T3 (pl) 2009-02-27
US20190275122A1 (en) 2019-09-12
ATE407693T1 (de) 2008-09-15
US8802087B2 (en) 2014-08-12
CN1933850B (zh) 2011-01-12
US20140302000A1 (en) 2014-10-09
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